Compression Device to Reduce Pocket Hematoma After Cardiac Implantable Electronic Device Implantation in a High Bleeding Risk Population

NCT06748573 | Completed

• 1 other identifier: 5671
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Your doctor has determined that you have an indication for cardiac implantation implantable electronic device (CIED = collective name for pacemaker or defibrillator). Pocket bleeding is a possible complication that occurs in 0.2-16% of cases depending on the definition used. They are an important risk factor for CIED infections (factor 9x). Other possible consequences include prolonged hospitalization risk of stroke due to discontinuation of blood thinners and even death. The main known risk factors for pocket bleeding are advanced age, heart failure, kidney failure, congenital bleeding tendency and the use of blood thinners. Have several measures to reduce the risk of pocket bleeding varying or limited effects shown in the past. Currently the standard treatment consists of applying a conventional pressure bandage at the pocket.However, the lack of targeted compression and lack of standardization has caused this only a limited effect and contributes to patient discomfort. Moreover, let a Conventional pressure dressing does not allow the pocket to be evaluated. The SafeGuard FocusTM compression bandage is a promising new option with several technical features advantages: it can deliver 2x as much pressure as a conventional pressure bandage, the amount pressure can be adjusted according to effect and patient comfort and there is a transparent window so that the surgical wound can always be inspected. This new pressure bandages already used in several countries, but has never been compared until now with a conventional pressure bandage.

Conditions

Pocket Hematoma

Keywords

pocket hematoma; compression device; cardiac implantable electronic device

Outcome Measures

Primary Outcomes (1)

• pocket hematome

  Grade I PH is defined as pocket ecchymosis or small effusion in the absence of swelling or pain. Grade II PH consists of large pocket effusion leading to swelling or pain. Grade III PH is characterized by the need of reoperation and/or hospitalization prolongation and/or interruption of antithrombotic drugs.

  24 hours

Secondary Outcomes (1)

• pain score

  24 hours

Study Arms (2)

Control arm

ACTIVE COMPARATOR

conventional compression bandage

Device: Conventional bandage

Study arm

EXPERIMENTAL

Study device (inflatable and see-through)

Device: SafeGuard FocusTM compression bandage

Interventions

SafeGuard FocusTM compression bandage DEVICE

If randomized to the study group, The study device was applied immediately after pocket closure using following steps: * Preparation: cleaning wound and surrounding area. * Placement: application of isobetadine gauze and transparent bandage. Study device placement at the level of the pocket. * Applying compression: inflation of 60ml of air. If oozing persisted 5ml increments were added (maximum of 120ml) until oozing stopped. The study device was gradually deflated by removal of 20ml of air every 2 hours. When oozing occurred 5ml increments were added until oozing stopped. When all air was deflated the study device was left in deflated mode and changed by conventional bandage at discharge.

Study arm

Conventional bandage DEVICE

If randomized to the control group, compressive bandage was applied immediately after pocket closure. The bandage was removed after 6 hours and changed by conventional bandage.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing primo CIED implantation (pacemaker, internal cardiac defibrillator or cardiac resynchronization therapy)
• with a high bleeding risk (as defined by at least 1 of the following risk factors: age \> 75 years, heart failure, kidney failure, antithrombotic use (double antiaggregant therapy or anticoagulation

You may not qualify if:

• refusal to participate
• mental illness

Sponsors & Collaborators

• Maxime Tijskens: lead
• Merit Medical Systems, Inc.: collaborator

Study Sites (1)

Cardiology

Wilrijk, Antwerp, 2610, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: The study is single-center, observational, case-controlled, randomized and prospective trail conducted at the ZAS heart center. Before CIED implantation, patients were randomly assigned in a 1:1 ratio to the study group (SafeGuard FocusTM compression device) or control group (standard care with compressive bandage) using a sealed envelope system. Inclusion criteria were all patients above 18 years of age undergoing primo CIED implantation (pacemaker, internal cardiac defibrillator or cardiac resynchronization therapy) with a high bleeding risk (as defined by at least 1 of the following risk factors: age \> 75 years, heart failure, kidney failure, antithrombotic use (double antiaggregant therapy or anticoagulation). Exclusion criteria were refusal to participate or mental illness.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 27, 2024
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)